Fertility Drug Alleged to Be a Dud, Resulting in Bravelle Recall and Plaintiff Litigation


. By Gordon Gibb

The Swiss-based drugmaker responsible for the fertility drug Bravelle recalled its medication with so little fanfare in the fall of last year that few noticed: it was left to clinics and pharmacies to break the news about the Bravelle recall to patients, who came in seeking refills.

However, industry analysts note that the Bravelle Infertility Drug Recall nonetheless met recall guidelines.

Ferring Pharmaceuticals Inc. announced in October 2015 that four lots of Bravelle sold in the United States and Canada between 2014 and 2015 had displayed “reduced potency” and could result in diminished therapeutic effect.

The Bravelle Recall involved lots of the drug that were found to be lower in strength and potency than specified. The drugmaker is reportedly working at trying to determine why that happened.

However, couples having paid thousands of dollars for an apparent dud aren’t waiting for answers, and are beginning to line up in the litigation pipeline with a Bravelle lawsuit. In Canada, attorneys directly involved with the file and a Bravelle Infertility Drug lawsuit filed by Joep and Amanda Olthuis told CTV News (2/16/16) that some 20 additional families have come out of the woodwork with similar complaints, and further state that it is their understanding hundreds of additional families across Canada are similarly affected.

The Bravelle lawsuit filed by the British Columbia couple has been put forward as a class action on behalf of couples similarly situated over a “loss of opportunity to have biological children.

“The Defendant may have squandered these women’s last opportunity to get pregnant, causing serious mental and emotional harm to couples who now may be unable to start families of their own,” a statement of claim submitted to the Supreme Court of British Columbia states.

In the United States, it’s a similar story. Angela and Daniel Lauruska of Holtsville, New York, launched their own class action Bravelle lawsuit April 15 (Lauruska et al v. Ferring Pharmaceuticals, Inc. Case No. 2:2016-cv-01857) in the US District Court for the Eastern District of New York. The New York Post (4/24/16) reported that the Long Island couple spent upwards of $30,000 on treatments with Bravelle and are out “thousands of dollars out-of-pocket.” They filed their Bravelle lawsuit in mid-April.

In announcing the Bravelle Infertility Drug Recall nine months ago, Ferring indicated at the time that the lots affected were “unlikely” to result in adverse side effects in the short term. However, according to CTV News, the company warned of a potential for “unnecessary overexposure” of patients in determining an effective dose.

In Canada, such overexposure would not be a problem for Joep and Amanda Olthuis. They could only afford one round of treatments that cost $14,000.

“It took us two years to save up the money,” Olthuis told CTV News. “I had to work six days a week…we didn’t go to movies, we didn’t go out for dinners…
“We scrounged, scraped and saved for two years because we wanted a family.”


Nine months after the Bravelle recall, there is no family for Joep and Amanda Olthuis.
But there is a Bravelle Infertility Drug lawsuit, and there will likely be others…


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